FDA Drug · D-0441-2023

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60

Class II · Terminated

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Affected lots / codes — check yours against thisLot #: 1410946A; Exp. 06/2023

Recalling firm: Teva Pharmaceuticals USA Inc, Parsippany, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 12,044 Bottles
Distribution: CA
Recall initiated: February 22, 2023
Classified: March 7, 2023
Terminated: December 6, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0441-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

See every recall for this brand: Is Teva Pharmaceuticals USA Inc recalled? →

Check this brand across all 8 databases →